Rationale and design of the iCORONARY trial: improving the cost-effectiveness of coronary artery disease diagnosis.

BACKGROUND: In patients with stable coronary artery disease (CAD), revascularisation decisions are based mainly on the visual grading of the severity of coronary stenosis on invasive coronary angiography (ICA). However, invasive fractional flow reserve (FFR) is the current standard to determine the haemodynamic significance of coronary stenosis. Non-invasive and less-invasive imaging techniques such as computed-tomography-derived FFR (FFR-CT) and angiography-derived FFR (QFR) combine both anatomical and functional information in complex algorithms to calculate FFR. TRIAL DESIGN: The iCORONARY trial is a prospective, multicentre, non-inferiority randomised controlled trial (RCT) with a blinded endpoint evaluation. It investigates the costs, effects and outcomes of different diagnostic strategies to evaluate the presence of CAD and the need for revascularisation in patients with stable angina pectoris who undergo coronary computed tomography angiography. Those with a Coronary Artery Disease-Reporting and Data System (CAD-RADS) score between 0-2 and 5 will be included in a prospective registry, whereas patients with CAD-RADS 3 or 4A will be enrolled in the RCT. The RCT consists of three randomised groups: (1) FFR-CT-guided strategy, (2) QFR-guided strategy or (3) standard of care including ICA and invasive pressure measurements for all intermediate stenoses. The primary endpoint will be the occurrence of major adverse cardiac events (death, myocardial infarction and repeat revascularisation) at 1 year. CLINICALTRIALS: gov-identifier: NCT04939207. CONCLUSION: The iCORONARY trial will assess whether a strategy of FFR-CT or QFR is non-inferior to invasive angiography to guide the need for revascularisation in patients with stable CAD. Non-inferiority to the standard of care implies that these techniques are attractive, less-invasive alternatives to current diagnostic pathways.

Machine learning-based prediction of insufficient contrast enhancement in coronary computed tomography angiography.

OBJECTIVES: Patient-tailored contrast delivery protocols strongly reduce the total iodine load and in general improve image quality in CT coronary angiography (CTCA). We aim to use machine learning to predict cases with insufficient contrast enhancement and to identify parameters with the highest predictive value. METHODS: Machine learning models were developed using data from 1,447 CTs. We included patient features, imaging settings, and test bolus features. The models were trained to predict CTCA images with a mean attenuation value in the ascending aorta below 400 HU. The accuracy was assessed by the area under the receiver operating characteristic (AUROC) and precision-recall curves (AUPRC). Shapley Additive exPlanations was used to assess the impact of features on the prediction of insufficient contrast enhancement. RESULTS: A total of 399 out of 1,447 scans revealed attenuation values in the ascending aorta below 400 HU. The best model trained using only patient features and CT settings achieved an AUROC of 0.78 (95% CI: 0.73-0.83) and AUPRC of 0.65 (95% CI: 0.58-0.71). With the inclusion of the test bolus features, it achieved an AUROC of 0.84 (95% CI: 0.81-0.87), an AUPRC of 0.71 (95% CI: 0.66-0.76), and a sensitivity of 0.66 and specificity of 0.88. The test bolus' peak height was the feature that impacted low attenuation prediction most. CONCLUSION: Prediction of insufficient contrast enhancement in CT coronary angiography scans can be achieved using machine learning models. Our experiments suggest that test bolus features are strongly predictive of low attenuation values and can be used to further improve patient-specific contrast delivery protocols. KEY POINTS: • Prediction of insufficient contrast enhancement in CT coronary angiography scans can be achieved using machine learning models. • The peak height of the test bolus curve is the most impacting feature for the best performing model.

Percutaneous coronary intervention versus medical therapy for chronic total coronary occlusions: a systematic review and meta-analysis of randomised trials.

BACKGROUND: The results of chronic total occlusion percutaneous coronary intervention (CTO-PCI) trials are inconclusive. Therefore, we studied whether CTO-PCI leads to improvement of clinical endpoints and patient symptoms when combining all available randomised data. METHODS AND RESULTS: This meta-analysis was registered in PROSPERO prior to starting. We performed a literature search and identified all randomised trials comparing CTO-PCI to optimal medical therapy alone (OMT). A total of five trials were included, comprising 1790 CTO patients, of whom 964 were randomised to PCI and 826 to OMT. The all-cause mortality was comparable between groups at 1­year [risk ratio (RR) 1.70, 95% confidence interval (CI) 0.50-5.80, p = 0.40] and at 4­year follow-up (RR 1.14, 95% CI 0.38-3.40, p = 0.81). There was no difference in the incidence of major adverse cardiac events (MACE) between groups at 1 year (RR 0.69, 95% CI 0.36-1.33, p = 0.27) and at 4 years (RR 0.85, 95% CI 0.60-1.22, p = 0.38). Left ventricular function and volumes at follow-up were comparable between groups. However, the PCI group had fewer target lesion revascularisations (RR 0.28, 95% CI 0.15-0.52, p < 0.001) and was more frequently free of angina at 1­year follow-up (RR 0.65, 95% CI 0.50-0.84, p = 0.001), although the scores on the subscales of the Seattle Angina Questionnaire were comparable. CONCLUSION: In conclusion, in this meta-analysis of 1790 CTO patients, CTO-PCI did not lead to an improvement in survival or in MACE as reported at long-term follow-up of up to 4 years, or to improvement of left ventricular function. However, CTO-PCI resulted in less angina and fewer target lesion revascularisations compared to OMT.

Incidence and outcomes of chronic total occlusion percutaneous coronary intervention in the Netherlands: data from a nationwide registry.

BACKGROUND: Patients with chronic total coronary occlusions (CTO) are at increased risk for poor clinical outcomes. We aimed to determine the incidence of CTO percutaneous coronary intervention (PCI) and to identify CTO patients at risk for cardiac events in the nationwide Netherlands Heart Registration (NHR). METHODS: We included all PCI procedures with ≥1 CTO registered in the NHR from January 2015 to December 2018, excluding acute interventions. We used multivariable logistic regression of baseline characteristics to calculate the risk for events as odds ratios (OR) with 95% confidence intervals (CI). RESULTS: Of the PCIs performed during the study period, 6.3% (8,343/133,042) were for CTOs, with the percentage increasing significantly over time from 5.9% in 2015 to 6.6% in 2018 (p < 0.001). Coronary artery bypass grafting <24 h was carried out in 0.3%, and the only significant predictor was diabetes mellitus (OR 2.97, 95% CI 1.04-8.49, p = 0.042). Myocardial infarction (MI) <30 days occurred in 0.5%, and renal insufficiency (i.e. estimated glomerular filtration rate <30 ml/min per 1.73 m2) was identified as an independent predictor (OR 4.70, 95% CI 1.07-20.61, p = 0.040). Among patients undergoing CTO-PCI, 1­year mortality was 3.7%, and independent predictors included renal insufficiency (OR 5.59, 95% CI 3.25-9.59, p < 0.001), left ventricular ejection fraction <30% (OR 3.43, 95% CI 2.00-5.90, p < 0.001), previous MI (OR 1.62, 95% CI 1.14-2.31, p = 0.007) and age (OR 1.06 per year increment, 95% CI 1.04-1.07, p < 0.001). Target-vessel revascularisation <1 year occurred in 11.3%. CONCLUSION: CTO-PCI is still infrequently performed in the Netherlands. The most important predictor of mortality after CTO-PCI was renal insufficiency. Identification of patients at risk may help improve the prognosis of CTO patients in the future.

Preoperative frailty parameters as predictors for outcomes after transcatheter aortic valve implantation: a systematic review and meta-analysis.

Guidelines suggest using frailty characteristics in the work-up for a transcatheter aortic valve implantation (TAVI). There are many frailty-screening tools with different components. The prognostic value of the individual parameters in frailty is as yet unclear. The objective of this systematic review and meta-analysis was to find and pool predictors for 1­year mortality after TAVI. We followed a two-step approach. First, we searched for randomised controlled trials on TAVI to identify frailty parameters used in these studies. Second, we searched for publications on these frailty parameters. Articles were included for pooled analysis if the studied frailty parameters were dichotomised with clear cut-off values based on common standards or clinical practice and reported adjusted hazard ratios (HR) of 1­year mortality after TAVI. We calculated pooled effect estimates of 49 studies based on dichotomised frailty scores (HR: 2.16, 95% CI: 1.57-3.00), chronic lung disease (HR: 1.57, 95% CI: 1.45-1.70), estimated glomerular filtration rate <30 ml/min (HR: 1.95, 95% CI: 1.68-2.29), body mass index <20 kg/m2 (HR: 1.49, 95% CI: 1.09-2.03), hypoalbuminaemia (HR: 1.77, 95% CI: 1.38-2.25), anaemia (HR: 2.08, 95% CI: 0.93-4.66), low gait speed (HR: 13.33, 95% CI: 1.75-101.49) and Katz activities of daily living (ADL) score of 1 or more deficits (HR: 5.16, 95% CI: 0.77-34.47). Chronic lung disease, chronic kidney disease, underweight, hypoalbuminaemia, a low frailty score, anaemia, low gait speed and an ADL deficiency were associated with worse 1­year outcomes after TAVI.

The Absorb bioresorbable vascular scaffold in real-world practice: long-term follow-up of the AMC Single Centre Real World PCI Registry.

BACKGROUND: Bioresorbable scaffolds have been introduced to overcome the shortcomings of drug-eluting stents. Higher rates of device thrombosis, however, have been reported up to 3 years after implantation of the Absorb bioresorbable vascular scaffold (BVS). In the current article, we therefore report long-term clinical outcomes of the AMC Absorb Registry. METHODS AND RESULTS: In the AMC Absorb Registry, all patients who underwent a percutaneous coronary intervention with Absorb BVS implantation between 30 August 2012 and 5 August 2013 at the Amsterdam University Medical Centre-Academic Medical Centre were included. The composite endpoint of this analysis was target-vessel failure (TVF). The median follow-up of the study cohort of the AMC Absorb Registry was 1534 days. At the time of the cross-sectional data sweep the clinical status at 4 years was known in 124 of 135 patients (91.9%). At long-term follow-up, the composite endpoint of TVF had occurred in 27 patients. The 4­year Kaplan-Meier estimate of TVF was 19.8%. At 4 years cardiac death had occurred in 4 patients (3.2%) and target-vessel myocardial infarction in 9 (6.9%) patients. Definite scaffold thrombosis occurred in 5 (3.8%) patients. We found 1 case of very late scaffold thrombosis that occurred at 911 days after device implantation in a patient who was not on dual anti-platelet therapy. CONCLUSION: In a patient population reflecting routine clinical practice, we found that cases of TVF continued to accrue beyond 2 years after Absorb BVS implantation.

Acute alterations in glucose homeostasis impact coronary microvascular function in patients presenting with ST-segment elevation myocardial infarction.

BACKGROUND: Microvascular dysfunction in the setting of ST-segment myocardial infarction (STEMI) is thought to be related to stress-related metabolic changes, including acute glucose intolerance. The aim of this study was to assess the relationship between admission glucose levels and microvascular function in non-diabetic STEMI patients. METHODS: 92 consecutive patients with a first anterior-wall STEMI treated with primary percutaneous coronary intervention (PPCI) were enrolled. Blood glucose levels were determined immediately prior to PPCI. After successful PPCI, at 1­week and 6­month follow-up, Doppler flow was measured in culprit and reference coronary arteries to calculate coronary flow velocity reserve (CFVR), baseline (BMR) and hyperaemic (HMR) microvascular resistance. RESULTS: The median admission glucose was 8.3 (7.2-9.6) mmol/l respectively 149.4 mg/dl [129.6-172.8] and was significantly associated with peak troponin T (standardised beta coefficient [std beta] = 0.281; p = 0.043). Multivariate analysis revealed that increasing glucose levels were significantly associated with a decrease in reference vessel CFVR (std beta = -0.313; p = 0.002), dictated by an increase in rest average peak velocity (APV) (std beta = 0.216; p = 0.033), due to a decreasing BMR (std beta = -0.225; p = 0.038) in the acute setting after PPCI. These associations disappeared at follow-up. These associations were not found for the infarct-related artery. CONCLUSION: Elevated admission glucose levels are associated with impaired microvascular function assessed directly after PPCI in first anterior-wall STEMI. This influence of glucose levels is an acute phenomenon and contributes to microvascular dysfunction through alterations in resting flow and baseline microvascular resistance.

Cardiology fellows-in-training are exposed to relatively high levels of radiation in the cath lab compared with staff interventional cardiologists-insights from the RECAP trial.

BACKGROUND: Interventional cardiologists are inevitably exposed to low-dose radiation, and consequently are at risk for radiation induced diseases like cataract and left-sided brain tumours. Operator behaviour may possibly be the largest influencer on radiation exposure. We hypothesised that awareness regarding radiation exposure grows as skill and the general experience in the catheterization laboratory increase. OBJECTIVES: In this study we determined the difference in the relative radiation exposure of staff interventional cardiologists compared with cardiology fellows-in-training. METHODS: During this prospective trial the operator's radiation exposure (E in µSv) was measured at chest height during 766 diagnostic catheterisations and percutaneous coronary interventions. Also, the patient exposure (DAP in mGy·cm2), representing the amount of radiation administered by the operator per procedure, was collected. The primary outcome of this study was the difference in relative exposure between staff interventional cardiologists versus cardiology fellows-in-training (E/DAP). RESULTS: From January to May 2017, staff interventional cardiologists performed 637 procedures and cardiology fellows-in-training 129 procedures. The performance of relatively complex procedures by staff interventional cardiologists resulted in a 74% higher use of radiation compared with fellows-in-training. Consequently, staff interventional cardiologists were exposed to 50% higher levels of actual radiation exposure. However, when correcting for the complexity of the procedure, by comparing the relative operator exposure (E/DAP), fellows-in-training were exposed to a 34% higher relative exposure compared with staff interventional cardiologists (p = 0.025). CONCLUSIONS: In the current study, when corrected for complexity, cardiology fellows-in-training were exposed to significantly higher radiation levels than staff interventional cardiologists during catheterisation procedures.

Short versus conventional hydration for prevention of kidney injury during pre-TAVI computed tomography angiography.

BACKGROUND: Computed tomography angiography (CTA) is required in the work-up for transcatheter aortic valve implantation (TAVI). However, CTA may cause contrast-induced acute kidney injury (CI-AKI). We hypothesised that a short (1 h, 3 ml/kg/h sodium bicarbonate) hydration protocol is not inferior to conventional (24 h, 1 ml/kg/h saline) hydration in avoiding a decline in renal function in patients with impaired renal function. METHODS AND RESULTS: Single-centre randomised non-inferiority trial in patients with impaired renal function who underwent pre-TAVI CTA. Patients were randomised on a 1:1 ratio to short hydration (SHORT; 1 h sodium bicarbonate, 3 ml/kg/h) or conventional hydration (CONV; 24 h saline, 1 ml/kg/h). Outcomes included percentage change in serum creatinine until 2-6 days after CTA with a non-inferiority margin of 10% and an increase on the Borg dyspnoea scale ≥1 point. Seventy-four patients were included. Increase in creatinine was 6 µmol/l (95% CI 2.5-9.3) in the SHORT versus 2 µmol/l (95% CI-1.4 to 6.3) in the CONV arm (p = 0.167). The percentage change was 4.6% (95% CI 2.0-7.3%) in the SHORT arm versus 2.5% (95% CI: 0.8 to 5.8%) in the CONV arm. The difference in percentage increase in creatinine between the two arms was 2.1% (95% CI: 2.0-6.2%; p-value non-inferiority: <0.001). CI-AKI and a need for dialysis were not observed. An increase of ≥1 point on the Borg scale (dyspnoea scale ranging from 1 (lowest) to 10 (highest)) was seen in 1 patient in the SHORT arm versus 5 patients in the CONV arm (2.9% vs 16.1%, p = 0.091). CONCLUSION: For patients with impaired renal function undergoing pre-TAVI CTA, a short 1­h, low-volume hydration protocol with sodium bicarbonate is not inferior to conventional 24-h, high-volume saline hydration.

Trends in patient characteristics and clinical outcome over 8 years of transcatheter aortic valve implantation.

AIM: In the evolving field of transcatheter aortic valve implantations (TAVI) we aimed to gain insight into trends in patient and procedural characteristics as well as clinical outcome over an 8­year period in a real-world TAVI population. METHODS: We performed a single-centre retrospective analysis of 1,011 consecutive patients in a prospectively acquired database. We divided the cohort into tertiles of 337 patients; first interval: January 2009-March 2013, second interval: March 2013-March 2015, third interval: March 2015-October 2016. RESULTS: Over time, a clear shift in patient selection was noticeable towards lower surgical risks including Society of Thoracic Surgeons predicted risk of mortality score and comorbidity. The frequency of transfemoral TAVI increased (from 66.5 to 77.4%, p = 0.0015). Device success improved (from 62.0 to 91.5%, p < 0.0001) as did the frequency of symptomatic relief (≥1 New York Heart Association class difference) (from 73.8 to 87.1%, p = 0.00025). Complication rates decreased, including in-hospital stroke (from 5.0 to 2.1%, p = 0.033) and pacemaker implantations (from 10.1 to 5.9%, p = 0.033). Thirty-day mortality decreased (from 11.0 to 2.4%, p < 0.0001); after adjustment for patient characteristics, a mortality-risk reduction of 72% was observed (adjusted hazard ratio [HR]: 0.28, 95% confidence interval [CI]: 0.13-0.62). One-year mortality rates decreased (from 23.4 to 11.4%), but this was no longer significant after a landmark point was set at 30 days (mortality from 31 days until 1 year) (adjusted HR: 0.69, 95% CI: 0.41-1.16, p = 0.16). CONCLUSION: A clear shift towards a lower-risk TAVI population and improved clinical outcome was observed over an 8­year period. Survival after TAVI improved impressively, mainly as a consequence of decreased 30-day mortality.

Mid-term and long-term safety and efficacy of bioresorbable vascular scaffolds versus metallic everolimus-eluting stents in coronary artery disease: A weighted meta-analysis of seven randomised controlled trials including 5577 patients.

AIMS: Mid- and long-term safety and efficacy of the Absorb bioresorbable vascular scaffold (BVS) have been studied in randomised trials; however, most were not individually powered for clinical endpoints. We performed a weighted meta-analysis comparing mid- and long-term outcomes in patients treated with the BVS compared with the Xience metallic stent. METHODS AND RESULTS: Randomised trials comparing the BVS and Xience were identified by searching MEDLINE, EMBASE and conference abstracts. Seven trials were included (BVS n = 3258, Xience n = 2319) with follow-up between 1-3 years. The primary outcome of target lesion failure occurred more frequently in BVS compared with Xience [OR 1.34; 95% CI 1.11-1.62, p = 0.003]. Overall definite or probable device thrombosis occurred more frequently with the BVS [OR 2.86; 95% CI 1.88-4.36, p < 0.001] and this extended beyond 1 year of follow-up [OR 4.13; 95% CI 1.99-8.57, p < 0.001]. Clinically indicated or ischaemia driven target lesion revascularisation [OR 1.43; 95% CI 1.11-1.83, p = 0.005] and myocardial infarction (all MI) [OR 1.64; 95% CI 1.20-2.23, p = 0.002] were more frequently seen in the BVS compared with Xience. Rates of target vessel failure [OR 1.15; 95% CI 0.91-1.46, p = 0.25] and cardiac death [OR 0.91; 95% CI 0.57-1.46, p = 0.71] were not significantly different between BVS and Xience. CONCLUSION: This meta-analysis shows a higher rate of target lesion failure and an almost threefold higher rate of device thrombosis in BVS compared with Xience, which extends beyond the first year. Device thrombosis did not lead to an overall increased (cardiac) mortality.

Coronary microcirculatory dysfunction is associated with left ventricular dysfunction during follow-up after STEMI.

BACKGROUND: Coronary microvascular resistance is increased after primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI), which may be related in part to changed left ventricular (LV) dynamics. Therefore we studied the coronary microcirculation in relation to systolic and diastolic LV function after STEMI. METHODS: The study cohort consisted of 12 consecutive patients, all treated with primary PCI for a first anterior wall STEMI. At 4 months, we assessed pressure-volume loops. Subsequently, we measured intracoronary pressure and flow velocity and calculated coronary microvascular resistance. Infarct size and LV mass were assessed using magnetic resonance imaging. RESULTS: Patients with an impaired systolic LV function due to a larger myocardial infarction showed a higher baseline average peak flow velocity (APV) than the other patients (26 ± 7 versus 17 ± 5 cm/s, p = 0.003, respectively), and showed an impaired variable microvascular resistance index (2.1 ± 1.0 versus 4.1 ± 1.3 mmHg cm(-1)∙s(-1), p = 0.003, respectively). Impaired diastolic relaxation time was inversely correlated with hyperaemic APV (r = -0.56, p = 0.003) and positively correlated with hyperaemic microvascular resistance (r = 0.48, p = 0.01). LV dilatation was associated with a reduced variable microvascular resistance index (r = 0.78, p = 0.006). CONCLUSION: A larger anterior myocardial infarction results in impaired LV performance associated with reduced coronary microvascular resistance variability, in particular due to higher coronary blood flow at baseline in these compromised left ventricles.

Cardiogenic shock: role of revascularization.

The most common cause of cardiogenic shock is myocardial ischemia developing early or late in the course of acute myocardial infarction. The incidence of cardiogenic shock (CS) is around 7% in ST-segment elevation myocardial infarction (STEMI) patients and has remained constant over the last 20 years. Therapy should be chain based by increased patient's awareness. Early and prehospital diagnosis and treatment, with prompt transfer to a catheterization laboratory. Early revascularization is the cornerstone treatment of acute myocardial infarction complicated by cardiogenic shock. According to the guidelines, revascularization is effective up to 36 hours after the onset of CS and performed within 18 hours after the diagnosis of CS. Primary percutaneous coronary intervention (PCI) is the most efficient and easily available therapy to restore coronary flow in the infarct related artery. Although recommended, there is little evidence that immediate multivessel PCI is beneficial for CS. The growing numbers of reports suggest staged PCI procedures or CABG is preferred in CS patients with significant LM disease or 3-vessel disease. The use of hemodynamic support with newly available percutaneous left ventricular unloading devices may herald a new era enabling preservation of adequate perfusion to other vital organs such as the brain, kidney and bowel. Despite all current efforts, in-hospital mortality for CS remains around 50%. However, long-term outcome and quality of life in hospital survivors is similar to patients with ST-segment elevation myocardial infarction patients presenting without CS.

[Support of damaged heart with the Impella pump]. / Ondersteuning van beschadigd hart met Impella-pomp.

Temporary mechanical circulatory support is increasingly used, particularly in patients with cardiogenic shock or during high-risk percutaneous coronary interventions. In the last five years there have been numerous developments in this field. Experience has been gained from usage of temporary heart pumps, and new pumps have arrived on the market. Until recently, the intra-aortal balloon pump was the standard treatment for patients with cardiogenic shock; however, results from the latest research into the effectiveness of this pump have rendered it less popular. An alternative modality is the Impella system. Since 2012, usage of a heart pump in cardiogenic shock treatment is reimbursed by healthcare insurers in the Netherlands. Recently, the FDA approved the Impella system for said indication.

Angiographic determinants of infarct size after successful percutaneous intervention for acute ST-elevation myocardial infarction: the impact of distal embolisation.

BACKGROUND: We investigated the impact of distal embolisation and other angiographic determinants in patients after successful primary angioplasty for acute myocardial infarction. METHODS: Angiographic data were assessed on the coronary angiogram carried out immediately after successful (TIMI 2 or 3) coronary angioplasty in 631 consecutive patients with acute myocardial infarction. Embolisation was defined as a distal filling defect with an abrupt 'cutoff' in ≥1 of the peripheral coronary artery branches of the infarct-related artery, distal to the site of angioplasty. Endpoints were left ventricular ejection fraction (LVEF) and enzymatic infarct size. RESULTS: Left anterior descending artery related myocardial infarction, impaired myocardial blush and distal embolisation were independent determinants of infarct size. Distal embolisation was present in 102 patients (16%) and was associated with a larger enzymatic infarct size (LDH Q48 2250 vs. 1532, p=0.001) and a lower LVEF (41% vs. 44%, p=0.04). There was no difference in the frequency of distal embolisation between patients treated with or without stents. CONCLUSIONS: In successful primary angioplasty, infarct-related artery, impaired myocardial blush and distal embolisation are independent determinants of infarct size. Distal embolisation can be visualised in 16% of the patients and is associated with a larger enzymatic infarct size and lower LVEF. Intracoronary stenting is not associated with an increased risk of distal embolisation during primary angioplasty.

Long-term clinical outcome of ST-segment elevation myocardial infarction patients with and without diabetes mellitus in the Zwolle trial.

OBJECTIVES: We sought to compare long-term survival after ST-segment elevation myocardial infarction (STEMI) in patients with and without diabetes mellitus (DM) treated with primary percutaneous coronary intervention (PCI) or thrombolytic therapy. BACKGROUND: DM is an adverse prognostic factor after STEMI. However, there is only limited information about long-term clinical outcome in STEMI patients with DM treated with PCI or thrombolysis. METHODS: Patients with STEMI (n=395) were randomised to treatment either with intravenous streptokinase or PCI. Mean follow-up was 8±2 years. We studied long-term mortality of patients with DM (n=32) and without DM (n=363) and the interaction with the treatment regimen. RESULTS: After eight years, a total of 17 patients with DM (53%) died compared with 88 (24%) patients without DM (OR 3.5, p<0.001). Reduced left ventricular ejection fraction (LVEF) after STEMI was more often present in patients with DM compared with patients without DM (31% vs. 15%, p=0.01). Multivariate analysis revealed that DM (OR 2.6, 95% CI 1.4-4.7, p=0.002), reduced LVEF (OR 2.4, 95% CI 1.5-3.8, p<0.001) and age ≥60 years (OR 2.4, 95% CI 1.5-3.8, p<0.001) were independent risk factors for long-term mortality. Patients with DM treated with PCI had less LVEF (13% vs. 53%, p=0.01) and lower long-term mortality rates (38% vs. 69%, p=0.08) compared with treatment with thrombolysis. CONCLUSIONS: STEMI patients with DM are a high-risk group with higher long-term mortality rates compared with patients without DM. PCI is the treatment of choice, particularly in DM patients.

Prognostic importance of left ventricular function after angioplasty or thrombolysis for acute myocardial infarction.

OBJECTIVES: To compare long-term clinical outcome after acute myocardial infarction treated with primary coronary angioplasty or thrombolytic therapy, and to study the determinants of survival. BACKGROUND: Primary coronary angioplasty results in a higher patency rate and a better short-term survival when compared with thrombolytic therapy, but so far limited information has been available regarding long-term clinical outcome. METHODS: Patients with acute myocardial infarction (n=395) were randomised to treatment with either intravenous streptokinase or primary angioplasty, and were followed for up to eight years. RESULTS: A total of 105 patients died, 42 patients in the primary coronary angioplasty group compared with 63 patients in the streptokinase group (p=0.03). Death and nonfatal reinfarction occurred in 53 patients in the angioplasty group, compared with 94 patients in the streptokinase group (p<0.001). The major cause of long-term mortality is sudden death. Multivariate analysis showed that left ventricular function was the most important predictor for both total mortality and sudden death. CONCLUSION: The benefits of primary coronary angioplasty compared with streptokinase are well sustained during long-term follow-up.